Recall Z-1275-2021— Sirtex Medical Limited
Class II · Terminated
Class II FDA medical device recall by Sirtex Medical Limited, initiated 2021-02-22, terminated 2023-04-17. FDA's recall record names no specific 510(k) clearance for this event. Product: SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.. Reason: There is a potential presence of particulate matter in the D-Vial..
- Recalling firm
- Sirtex Medical Limited
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-02-22
- Terminated
- 2023-04-17
- Firm location
- North Ryde, New South Wales, N/A, Australia
Product description
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
Reason for recall
There is a potential presence of particulate matter in the D-Vial.
Data sourced from openFDA. This site is unofficial and independent of the FDA.